At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 10 enrolled
Drug / intervention
Inotuzumab Ozogamicin (CMC-544) +1 moredrug
Likely dose
Inotuzumab Ozogamicin (CMC-544) 1.8 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With B-cell Non-hodgkin's Lymphoma
In Brief
A Phase 1 clinical trial evaluating Inotuzumab Ozogamicin (CMC-544) and Rituximab (Rituxan) for Lymphoma, B-Cell. Completed, enrolled 10 participants across 4 sites.
Detailed Summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, B-Cell
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionMar 2010
TodayJul 2026
First PostedJul 30, 2008
Enrollment StartJul 4, 2008
Primary CompletionMar 10, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.9 years ago
Interventions
Inotuzumab Ozogamicin (CMC-544)drug
1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.
Rituximab (Rituxan)drug
375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs.